小窩裂溝う蝕予防における高粘度ガラスアイオノマーとレジンシーラントの有効性試験．2 年間の Split Mouth Randomized Controlled Trial を行った

An Efficacy Study between High Viscosity Glass Ionomers and Resin Sealants in Fissure Caries Prevention: A 2-Year Split Mouth Randomized Controlled Trial.

抄録

目的:

この臨床試験は、インド南部テランガナ州の学童の一部を対象に、24 ヶ月間にわたり、外傷性修復治療（ART）シーラントとレジン系シーラントの保存性と小窩裂溝う蝕予防効果について比較検討した。

OBJECTIVES:  This clinical trial compared the efficacy of atraumatic restorative treatment (ART) sealants against resin-based sealants in terms of their retention and fissure caries preventive benefits over a period of 24 months among a section of school children in the Southern Indian state of Telangana.

材料と方法:

198名の児童を対象とした分割口唇臨床試験で、下顎第一大臼歯にこれらのシーラントを行った。統計解析：カイ二乗検定を用い、両群間のシーラント保持率およびう蝕発生率を解析した。Kaplan-Meier生存分析により，両群のシーラント保持率（部分保持，完全保持）とう蝕のない小窩裂溝保持率の累積生存率をプロットした．また，線形二項ロジスティック回帰分析により，オッズ比を算出した．

MATERIALS AND METHODS:  A split mouth clinical trial employed 198 children, who received these sealants on their lower permanent first molars. Retention was assessed 6 monthly and caries annually STATISTICAL ANALYSIS:  Chi-square tests were utilized to analyze the retention rate and the incidence of dental caries between the two groups. Kaplan-Meier survival analysis plotted the cumulative survival percentage of partially, and fully retained sealants and the survival of dentin carious free pits and fissures among both the groups. A linear binary logistical regression analysis calculated the odds ratio.

結果:

両群のシーラント保持率には，すべての経過観察段階において統計学的に有意な差が認められた．2年後までの累積生存率は，ARTが30.9％，レジンシーラントが37.5％と算出された．Kaplan-Meier解析では，象牙質う蝕のない小窩裂溝部の生存率に関して，有意差は認められなかった．本試験のオッズ比は0.747（95％信頼区間：0.493-1.13）結論：レジンシーラントは，保定の分野ではARTシーラントよりも良好であった．しかし，研究期間終了時の小窩裂溝う蝕予防に関しては，有意差は認められなかった．

RESULTS:  A statistical significant difference was observed in the retention rate between these sealants at every follow-up stage. The cumulative survival percentage of ART and resin sealants was calculated to be 30.9 and 37.5% by the end of 2 years. The Kaplan-Meier analysis showed no significant difference with regard to the survival of dentin carious free pits and fissures. The odds ratio for this trial was 0.747 (95% confidence interval: 0.493-1.13) CONCLUSION:  Resin sealants fared better than ART sealants in the field of retention. However, no significant differences were observed with regard to fissure caries prevention by the end of the study period.